Recalled Medical Devices: How to Check If You Have One

Numerous medical devices sold in the United States are subject to active recalls. If you have a medical device that is subject to an active recall, it will be important to make sure you know what this means for your health and your legal rights. The health consequences of medical device defects can vary widely, and, in all cases, patients who experience complications can (and should) seek just compensation for their losses. Tragically, some medical device defects can prove fatal—and, in these cases, patients’ family members can take legal action as well.

How to Find Out if a Medical Device Has Been Recalled

So, how can you find out if your (or a loved one’s) medical device has been recalled?

The U.S. Food and Drug Administration (FDA) maintains a searchable database of recalled products on its website. That database is available here: Recalls, Market Withdrawals, & Safety Alerts.

When you visit the FDA’s database, you have the option of searching specifically for medical devices, and you can choose whether to search for active or terminated recalls.

The FDA also separately maintains a list of medical device recalls, and, according to the FDA, this list is more comprehensive than its searchable database. However, it is also more difficult to navigate. As a result, we recommend checking both sources to find out if your (or a loved one’s) medical device is subject to an active or terminated recall.

Some examples of recent additions to these resources include:

• Abbott Laboratories HeartMate Mobile Power Unit
• Abiomed Impella RP Heart Pump
• Biosense Webster Varipulse Ablation Catheter
• Boston Scientific Corporation Accolade Pacemaker
• Hologic BioZorb 3D Bioabsorbable Markers
• Medline Industries Integrated Arterial Catheters
• Medtronic Aortic Root Cannula
• Medtronic MiniMed 600 Series and 700 Series Insulin Pumps
• Smiths Medical Portex Intubation Oral/Nasal Endotracheal Tubes
• Smiths Medical ProPort Plastic Implantable Port

Again, these are just examples—these are not all of the medical devices that are currently subject to (or that have recently been subject to) recalls in the United States.

Along with checking the FDA’s website, patients and family members who have concerns can also check the manufacturer’s website for press releases, product updates, and other sources of recall-related information. In some cases, major medical device recalls will make headlines as well. Consulting with your (or your loved one’s) doctor is also an option—and medical providers should have up-to-date information on the recall status of the medical devices they supply to their patients.

Understanding What It Means if a Medical Device Has Been Recalled

If you (or a loved one) has received a medical device that is subject to a recall, it will be important to find out exactly what this means for your (or your loved one’s) health. This is because medical device recalls can mean different things in different circumstances. For example, broadly speaking, the FDA divides medical device recalls into three categories, or “Classes”:

• Class I Medical Device Recall – A Class I medical device recall involves “a situation in which there is a reasonable probability that the use of, or exposure to, [the medical device] will cause serious adverse health consequences or death.”
• Class II Medical Device Recall – A Class II medical device recall involves “a situation in which use of, or exposure to, [the medical device] may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
• Class III Medical Device Recall – A Class III medical device recall involves “a situation in which use of, or exposure to, [the medical device] is not likely to cause adverse health consequences.”

A Class I medical device recall is significantly more serious than a Class III medical device recall—and, while a Class I recall may warrant having a medical device removed, this is far less likely to be the case when a recall falls into Class III. With that said, every recall is different, and patients and their loved ones should consult with their healthcare providers to ensure that they are making informed decisions.

Another important factor to consider is the nature of the recall. As the FDA explains, a “recall” can involve either “removal or correction of a marketed product.” A correction generally involves a modification that does not require pulling a device from healthcare providers’ shelves (i.e., an update to the instructions for implantation or use), while a removal does generally involve stopping use of the product, at least for a period of time. Here, too, your (or your loved one’s) doctor should be able to explain what you need to know.

What if You or a Loved One Has Been Harmed By a Recalled Medical Device?

Sadly, many patients don’t learn that their medical devices have been recalled until it is too late. If you or a loved one has been harmed by a recalled medical device, you may have grounds to take legal action, and you will want to consult with a lawyer about your legal rights.

In many cases, recalled medical devices can be classified as “defective.” When manufacturers sell defective medical devices, they can be held fully accountable for the harm that their devices cause. If you have a legal claim for a defective medical device, you can hire a lawyer to represent you at no out-of-pocket cost, and your lawyer can help you seek just compensation for your out-of-pocket expenses, loss of income, pain and suffering, and other losses. These losses can be substantial, and patients and families will often be able to seek significant settlements from defective medical device manufacturers.

Contact the Defective Medical Device Lawyers at Searcy Denney

Do you need to know more about filing a claim for a defective medical device? If so, the defective medical device lawyers at Searcy Denney can explain your legal rights and help you make informed decisions about your next steps. To schedule a free, no-obligation consultation at a time that is convenient for you, please call  800-780-8607 or tell us how we can help online today.